NCT03535272

Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea

Bismuth Subsalicylate's Role in the Prevention of Travelers' Diarrhea and Impact on Acquisition of Gut Antimicrobial Resistance Genes

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 482 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if the use of prophylactic bismuth subsalicylate (BSS) has an effect on the acquisition of travelers' diarrhea (TD) or antimicrobial resistance (AMR) genes in fecal samples among international travelers who departed from the United States to South East Asia, South Central Asia, or Africa. Our hypotheses will be tested using a double-blinded, placebo controlled randomized clinical trial with participants from a pre-travel health clinic in the United States.

Conditions

• Diarrhea Travelers
• Antibiotic Resistant Infection

Interventions

Type	Name	Description
DRUG	Bismuth subsalicylate	We aim to determine if there is a biologic benefit to an intervention (BSS administration) in the acquisition of travelers diarrhea and the acquisition of antimicrobial resistance genes.
DRUG	Placebo Oral Tablet	Placebo manufactured to mimic pepto bismol

Timeline

• Start date: 2018-05-20
• Primary completion: 2023-11-01
• Completion: 2023-12-31
• First posted: 2018-05-24
• Last updated: 2026-04-02
• Results posted: 2025-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study